Statins Can Cause Disabling Muscle Disease

It seems that Big Pharma just won’t give up.  I expect all sorts of comments about thisarticle and studies to disprove what it says. 

Statin medications, such as Crestor, Lipitor, and other lipid-lowering medications, have been prescribed increasingly in recent years to reduce cardiovascular disease and mortality in high risk individuals. Many doctors now recommend these medications even for patients who have never demonstrated a cardiac risk.

One of the side effects of these drugs, however, is muscle pain and weakness, a general condition called “myositis.” In the great majority of patients, this side effect goes away when they stop taking the medication. For some, however, especially those who test positive for anti-HMGCR antibodies in their blood, this myositis can be a much more serious complication, one that can have a devastating impact on the patient’s health for the rest of their lives.

For some patients, statins cause necrotizing myopathy, a form of the rare idiopathic inflammatory myopathy, also known as myositis. Myositis is a chronic, debilitating condition that includes dermatomyositis, polymyositis, inclusion-body myositis, and juvenile forms of the disease. Necrotizing myopathy does not resolve after the statin is stopped, leaving patients with life-long challenges doing even simple things like standing from a seated position, climbing stairs, and even lifting their arms over their heads.

Myositis patients, including those with necrotizing myopathy, face other life-threatening disorders, including interstitial lung disease, antisynthetase syndrome, and a higher risk of cancer and other diseases. While there is no cure for this chronic, disabling condition, many patients can successfully be treated with anti-inflammatory medications.

That’s why other treatments other than statins must be considered for those who may be at risk for developing necrotizing myopathy. According to UCLA rheumatologist and myositis specialist Christina Charles-Schoeman, MD, those who have “statin” myositis should never take statins. “They need immune treatment for their myositis, and they usually improve greatly,” she says. “Luckily, this is a very rare disease and does not occur for the vast majority of patients taking statins.”

The Myositis Association is an international nonprofit organization committed to support and education for myositis patients and caregivers, increasing awareness of myositis throughout the community and among physicians, and funding for myositis-related research.

Hopefully, researchers will not bend to the will of Big Pharma. Read my blogs here and here about the problems of statins.

When Will Doctors Believe in Statin Damage?

Most doctors will continue to insist on prescribing statins, but more and more evidence is coming to light about the damage to our bodies being caused by statins. Increasing numbers of Americans are being prescribed statin drugs to lower their risk of heart attack or stroke. The risks of these drugs to muscles and kidneys may be greater than previously thought.

Statins are also associated with a higher risk of type 2 diabetes and with more rapid deterioration in patients with chronic kidney disease.

Duane Graveline, M.D., M.P.H., and Philip W. Blair, M.D. writing in the spring issue of the Journal of American Physicians and Surgeons say, “The risks of these drugs to muscles and kidneys may be greater than previously thought.” Graveline and Blair calculate that between 2005 and 2011 there may have been nearly 2,000 deaths from rhabdomyolysis due to statins, based on the FDA's MedWatch records.

Authors conclude that statin-associated muscle and kidney damage are both more common and more insidious than generally believed. The "collateral damage is probably higher than most clinicians would consider acceptable." They advocate restricting statin usage until more is known about these effects.

Damage may be occurring even if the patient's CPK levels are normal, authors state. CPK (creatine phosphokinase) is the blood test doctors monitor to check for muscle damage. Although rhabdomyolysis is generally considered to be an acute crisis, there is a chronic progressive form as in the case report in the article.

Some 24 percent of Americans have a gene called SNIPS, which causes blood levels of statins to be much higher than expected, authors warn.

Also read my blog about statins causing hardening of the arteries, which was not reported in this study.

With all the bad news being found in studies lately, it is hoped that doctors will slow their efforts to over prescribe statins, but the American Heart Association is not backing down in their efforts to prescribe statins to more people. They are even pushing for prescribing to people that have normal lipid panels and young people.

Those of us following the research know that people are abandoning statins in greater numbers and won't allow future prescriptions, even if they are labeled non-compliant.

Statins May Increase Kidney Disease

This should make everyone take notice. Long-term statin use may increase kidney disease. While we are all familiar with statins increasing the risk of type 2 diabetes, this is somewhat of a surprise, but seems logical. Many of the drugs of today have more and more side effects and many can cause harms to patients.

Considering that statins have no proven cardiovascular disease prevention or life lengthening effects, it seems that the statins all have more harm causing properties than health improving properties.

In a December 1, 2015 issue of the American Journal of Cardiology, lead author Dr, Tushar Acharya of the University of California, San Francisco, said an 8-year retrospective study with a median 6.4 year follow-up associated long-term statin use with an increased risk of kidney disease. Statin users, compared with case-matched controls that didn't use statins, showed a 30% to 36% greater prevalence of kidney disease during follow-up.

Senior author Dr. Ishak A Mansi, University of Texas Southwestern, Dallas, said, “Patients who are taking statins should not stop taking them based on this study. Our study did not examine whether the benefits outweigh the risk, as it was not designed for that. Still, this study shows that despite the use of statins for more than a quarter of a century, there are aspects about its long-term effects in noncardiac diseases that we do not know very well. We are missing more extensive, real-world data of the effectiveness of statins on total morbidity and all-cause mortality, and we need further studies specifically focusing on long-term outcomes in primary prevention."

Dr. Mansi continued, “The new [ACC] guidelines . . . are projected to increase statin use to many more hundreds of millions of healthy people, and before we do that we better make sure that we are not causing harm. Our paper says to scientists, physicians, funding agencies, [and] policy makers: 'Watch out, [it] seems that we still do not know enough about the long-term effects of these drugs on [the] overall well-being of patients.'"

The overall cohort comprised 43,438 individuals: 13,626 statin users and 29,812 nonusers. The most commonly prescribed statin was simvastatin (73.5%), followed by atorvastatin (17.4%), pravastatin (7%), and rosuvastatin (Crestor, AstraZeneca) (1.7%); 38% of the statin users received high-intensity doses. The statin users took the drugs for a mean of 4.65 years.

The researchers matched 6342 statin users in the overall cohort with 6342 nonusers, according to baseline demographics, comorbidities, and presence of renal disease, healthcare utilization, and medication use. In this matched cohort, patients had a mean age of 56, and 45% were women.

"The findings of this study, though cautionary, suggest that short-term [randomized controlled trial] may not fully describe long-term adverse effects of statins," Acharya and colleagues conclude. Statins lower the risk of cardiovascular disease and cardiovascular death, but "on the other hand, statins increase the risk of incident diabetes and possibly kidney diseases, both of which paradoxically increase long-term morbidity and mortality," they continue.

Statins Up the Risk for Type 2 Diabetes – Part 3

To relieve statin side effects, your doctor may recommend several options. Discuss the following steps with your doctor before trying them:

#1 Take a brief break from statin therapy. Sometimes it's hard to tell whether the muscle aches or other problems you're having are statin side effects or just part of the aging process. Taking a break of 10 to 14 days can give you some time to compare how you feel when you are and aren't taking a statin. This can help you determine whether your aches and pains are due to statins instead of something else.

#2 Switch to another statin drug. It's possible, although unlikely, that one particular statin may cause side effects for you while another statin won't. It's thought that simvastatin (Zocor) may be more likely to cause muscle pain as a side effect than other statins when it's taken at high doses. Newer statin drugs are being studied that may have may have fewer side effects.

#3 Change your dose. Lowering your dose may reduce some of your side effects, but it may also reduce some of the cholesterol-lowering benefits your medication has. It's also possible your doctor will suggest switching your medication to another statin that's equally effective but can be taken in a lower dose. For example, if you've successfully taken atorvastatin (Lipitor) for a long time at higher doses, your doctor may keep you at this level. However, higher doses aren't recommended if you're new to this medication.

Take it easy when exercising. It is possible exercise could make your muscle aches worse. Talk to your doctor about changing your exercise routine.

Consider other cholesterol-lowering medications. Taking ezetimibe (Zetia), a cholesterol absorption inhibitor medication, may help you avoid taking higher doses of statins. However, some researchers question the effectiveness of ezetimibe compared with statins in terms of its ability to lower your cholesterol.

Don't try over-the-counter (OTC) pain relievers. Muscle aches from statins can't be relieved with acetaminophen (Tylenol, others) or ibuprofen (Advil, Motrin IB, others) the way other muscle aches are. Don't try an OTC pain reliever without asking your doctor first.

Try coenzyme Q10 supplements. Coenzyme Q10 supplements may help to prevent statin side effects in some people, though more studies are needed to determine any benefits of taking it. If you'd like to try adding coenzyme Q10 to your treatment, talk to your doctor first to make sure the supplement won't interact with any of your other medications. Some people need this supplement and do well when taking it.

Be careful and watch for drug interactions. Some of the following are extremely important. The first one I was not warned about and I have a very serious drug interaction. See my blog here.

Statins can have several potentially dangerous interactions with other medications and some foods. These interactions can make it more likely you'll have statin side effects. These include:

#1 All statins and grapefruit or grapefruit juice. Grapefruit juice contains a chemical that can interfere with the enzymes that break down (metabolize) the statins in your digestive system. This can be dangerous because it's uncertain what the effect would be on your total cholesterol. You should still be able to have some grapefruit or grapefruit juice, but talk to your doctor about limiting how much grapefruit you can have.

#2 Lovastatin (Mevacor, Altoprev) or simvastatin (Zocor) and amiodarone (Cordarone). People taking the statins lovastatin or simvastatin, either alone or in combination with amiodarone (Cordarone), a medication for irregular heart rhythms, are at a greater risk of severe statin side effects, such as rhabdomyolysis.

#3 All statins and gemfibrozil (Lopid). People who take both gemfibrozil (Lopid) and a statin may be at a greater risk of statin side effects.

#4 Mevacor (lovastatin) and HIV drugs. Medicines used to treat HIV (protease inhibitors) should never be taken with Mevacor.

#5 All statins and some antibiotic and antifungal medications. If you have a fungal or bacterial infection, be sure to tell your doctor if you take a statin.

#6 All statins and some antidepressant medications. It's possible that taking antidepressants, such as nefazodone, and a statin could make you more likely to have muscle aches.

#7 All statins and some immunosuppressant medications. If you take a medication to suppress your immune system, such as cyclosporine (Sandimmune), and a statin, you may be more likely to have muscle aches.

Weigh the risks and benefits

Although statin side effects can be annoying, consider the benefits of taking a statin before you decide to stop taking your medication. Remember that statin medications can reduce your risk of a heart attack or stroke, and the risk of life-threatening side effects from statins is very low.

Even if your side effects are frustrating, don't stop taking your statin medication for any period of time without talking to your doctor first. Your doctor may be able to come up with an alternative treatment plan that can help you lower your cholesterol without uncomfortable side effects.

Be careful because some doctors just will ignore taking you off statins (they don't wish to diminish the cash flow coming in). Other doctors do not honestly know how to a risk /benefits analysis.

Statins Up the Risk for Type 2 Diabetes – Part 2

I cannot say that statins caused my diabetes because I had diabetes when statins were prescribed. I can say that I did ask to have to dose reduced because of muscle problems I was having. Reducing the dose has helped and the muscle pain has gone away.

The largest problem is that doctors are prescribing statins willy-nilly and most are not doing a benefits-harm analysis. In addition many doctors are not allowing patients to even attempt to lower cholesterol levels by other means or allowing them to eliminate statins when the have shown that they have lowered their cholesterol levels. Many doctors are also trying to increase the statin dose being taken by patients.

For many people, statin side effects negate any benefits. The statin side effects include:

#1 Muscle pain and damage. This is the most common side effect. You may feel this pain as a soreness, tiredness, or weakness in your muscles. The pain can be a mild discomfort, or it can be severe enough to make your daily activities difficult. For example, you might find climbing stairs or walking to be uncomfortable or tiring.

Very rarely, statins can cause life-threatening muscle damage called rhabdomyolysis. Rhabdomyolysis can cause severe muscle pain, liver damage, kidney failure, and death. Rhabdomyolysis can occur when you take statins in combination with certain drugs or if you take a high dose of statins.

#2 Liver damage. Occasionally, statin use can cause your liver to increase its production of enzymes that help you digest food, drinks, and medications. If the increase is only mild, you can continue to take the drug. Rarely, if the increase is severe, you may need to stop taking the drug. Your doctor might suggest a different statin. Certain other cholesterol-lowering drugs, such as gemfibrozil (Lopid) and niacin (Niacor, Niaspan), slightly increase the risk of liver problems in people who take statins.

Although liver problems are rare, your doctor will likely order a liver enzyme test before or shortly after you begin to take a statin. You shouldn't need any additional liver enzyme tests unless you begin to have signs or symptoms of trouble with your liver. Contact your doctor immediately if you have unusual fatigue or weakness, loss of appetite, pain in your upper abdomen, dark-colored urine, or yellowing of your skin or eyes.

#3 Digestive problems. Some people taking a statin may develop nausea, gas, diarrhea, or constipation after taking a statin. These side effects are rare. Most people who have these side effects already have other problems with their digestive system. Taking your statin medication in the evening with a meal can reduce digestive side effects.

#4 Rash or flushing. You could develop a rash or flushing after you start taking a statin. If you take a statin and niacin, either in a combination pill such as Simcor or as two separate medications, you're more likely to have this side effect. Taking aspirin before taking your statin medication may help, but talk to your doctor first.

#5 Increased blood sugar or type 2 diabetes. It is possible your blood glucose level may increase when you take a statin, which may lead to developing type 2 diabetes. The risk level is being disputed, but important enough that the Food and Drug Administration (FDA) has issued a warning on statin labels regarding blood glucose levels and diabetes. Talk to your doctor if you have concerns.

#6 Neurological side effects. The FDA warns on statin labels that some people have developed memory loss or confusion while taking statins. These side effects reverse once you stop taking the medication. Talk to your doctor if you experience memory loss or confusion. There has also been evidence that statins may help with brain function, in patients with dementia or Alzheimer's, for example. This is still being studied. Don't stop taking your statin medication before talking to your doctor.

Who's at risk of developing statin side effects? Not everyone who takes a statin will have side effects, but some people may be at a greater risk than are others. Risk factors include:

• Taking multiple medications to lower your cholesterol
• Being female
• Having a smaller body frame
• Being age 65 or older
• Having kidney or liver disease
• Having type 1 or 2 diabetes
• Drinking too much alcohol (More than two drinks a day for men age 65 and younger and more than one drink a day for women of all ages and men older than 65)

What causes statin side effects? It's unclear what causes statin side effects, especially muscle pain. Statins work by slowing your body's production of cholesterol. Your body produces all the cholesterol it needs by digesting food and producing new cells on its own. When this natural production is slowed, your body begins to draw the cholesterol it needs from the food you eat, lowering your total cholesterol.

Statins may affect not only your liver's production of cholesterol but also several enzymes in muscle cells that are responsible for muscle growth. The effects of statins on these cells may be the cause of muscle aches.